Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTIUM USA IMPLANTIUM; IMPLANT, ENDOSSEOUS, ROOT-FORM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DENTIUM USA IMPLANTIUM; IMPLANT, ENDOSSEOUS, ROOT-FORM Back to Search Results
Model Number FX4308MLC
Medical Device Problem Codes Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 01/03/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The dental implant, fx4308mlc in tooth location #2 was removed on (b)(6) 2017 due to loss of osseointegration 1 year and 8 months after implantation.The doctor indicated that the bone condition caused the implant removal.The patient didn't have any medical history.The patient has been recovered without complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IMPLANTIUM
Common Device Name
IMPLANT, ENDOSSEOUS, ROOT-FORM
Manufacturer (Section D)
DENTIUM USA
6761 katella avenue
cypress CA 90630
MDR Report Key6363270
Report Number3005503242-2017-00001
Device Sequence Number11006664
Product Code DZE
UDI-Device IdentifierD755FX4308MLC0
UDI-PublicD755FX4308MLC0
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K041368
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Dentist
Type of Report Initial
Report Date (Section B) 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Dentist
Device Expiration Date03/31/2022
Device Model NumberFX4308MLC
Device Lot NumberB21TA540S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/11/2017
Initial Report FDA Received Date02/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
-
-